Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2025-12-31 @ 11:22 PM
Study NCT ID:
NCT03897569
Status:
COMPLETED
Last Update Posted:
2019-07-30
First Post:
2019-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association Between Ankle Dorsiflexion and Frontal Projection Angle in PFPS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046788', 'term': 'Patellofemoral Pain Syndrome'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-28', 'studyFirstSubmitDate': '2019-03-27', 'studyFirstSubmitQcDate': '2019-03-29', 'lastUpdatePostDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frontal knee kinematic', 'timeFrame': '20 minutes', 'description': 'The knee kinematic will be measured by using digital video camera using single leg squat during functional step down test'}], 'secondaryOutcomes': [{'measure': 'Ankle mobility', 'timeFrame': '20 minutes', 'description': 'Ankle dorsiflexion ROM will be assessed by bubble inclinometer during weight-bearing and non-weight-bearing positions.'}]}, 'conditionsModule': {'keywords': ['Patellofemoral Pain Syndrome', 'knee kinematics', 'frontal projection angle', 'ankle motion'], 'conditions': ['Patellofemoral Pain Syndrome']}, 'descriptionModule': {'briefSummary': 'The study will investigate an association between ankle dorsiflexion and altered frontal knee kinematics during step down test in patients with PFPS.', 'detailedDescription': 'Altered frontal and transverse plane hip kinematics during single leg weight-bearing tasks are thought to be important contributors to patellofemoral pain (PFP). The closed chain nature of single leg tasks means that hip kinematics can be influenced by more distal mechanics, such as foot pronation.\n\nOne of the often-studied distal movements theorized to cause PFPS is pronation of the subtalar joint. Pronation is a tri-planar movement that includes dorsiflexion, eversion, and abduction of the foot. Many studies have examined eversion characteristics of PFPS patients, but the dorsiflexion aspect of the movement has been shown to be a possible risk factor, restricting dorsiflexion was shown to increase medial knee displacement in young healthy adults. Conversely, when available dorsiflexion ROM is increased, medial knee displacement is thought to decrease.\n\nPatients with PFPS were observed to have a decreased DFROM (dorsiflexion range of motion) as compared to normal individuals, though this topic has not thoroughly been investigated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects between 18 to 35 years old with symptomatic patellofemoral pain syndrome and healthy control.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Anterior or retropatellar knee pain from at least 2 of the following Activities : (1) prolonged sitting; (2) stair climbing; (3) squatting; (4) running; (5) kneeling; and (6) hopping/jumping.\n2. Insidious onset of symptoms unrelated to a traumatic incident and persistent for at least 6weeks.\n3. VAS equal to or greater than 3.\n4. Age of the subject 18-35 years to limit the possibility that PFPS over age 35 may have been complicated by arthritic changes, and also the subjects should have closed epiphyseal growth plates.\n5. BMI under 30 kg/m2, both gender\n\nFor the control group, subjects were recruited to this study if they had:\n\n1. No previous history or diagnosis of knee pathology.\n2. No pain with any of the above-mentioned provocative activities.\n3. No history of lower limb or spinal pathology.\n\nExclusion Criteria:\n\n1. A history of any of the following condition: meniscal or other intraarticular pathologic conditions; cruciate or collateral ligament involvement.\n2. A history of traumatic patellar subluxation or dislocation.\n3. Previous surgery in the lower extremities within the 12 months prior to participation in the study.\n4. Any balance impairments are secondary to a vestibular or neurological disorder or secondary to the use of medication.\n5. Any lower limb bony/congenital deformity'}, 'identificationModule': {'nctId': 'NCT03897569', 'briefTitle': 'Association Between Ankle Dorsiflexion and Frontal Projection Angle in PFPS', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Association Between Ankle Dorsiflexion and Frontal Projection Angle During a Functional Task in the Patellofemoral Pain Syndrome', 'orgStudyIdInfo': {'id': 'PFPS kinematics'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patellofemoral pain syndrome', 'description': 'twenty subjects with anterior or retropatellar knee pain from at least 2 of the following Activities : (1) prolonged sitting; (2) stair climbing; (3) squatting; (4) running; (5) kneeling; and (6) hopping/jumping.', 'interventionNames': ['Other: frontal projection angle, ankle dorsiflexion']}, {'label': 'control', 'description': 'twenty-six asymptomatic subject will be recruited for this study and should have no pain or other relevant clinical symptoms in the lower quadrant', 'interventionNames': ['Other: frontal projection angle, ankle dorsiflexion']}], 'interventions': [{'name': 'frontal projection angle, ankle dorsiflexion', 'type': 'OTHER', 'description': 'Dorsiflexion measurements will be taken in 4 different positions and repeated and recorded 3 times in each position, Prone bent, straight knee and Standing bent, straight knee. Prior to the measurement, the participants completed two 30-second calf stretches The FPPA was determined as the angle at the knee formed by lines connecting the anterior superior iliac spine, the midpoint of the femoral condyles and the midpoint of the malleoli at the deepest part of the squat', 'armGroupLabels': ['control', 'patellofemoral pain syndrome']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'egypt', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Physical therapy, Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'karima A Hassan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Karima Abdelaty Hassan', 'investigatorAffiliation': 'Cairo University'}}}}